A Randomized, Single-Blind Clinical Trial Comparing Robotic-Assisted Fluoroscopic-Guided with Ultrasound-Guided Renal Access for Percutaneous Nephrolithotomy

Abstract

PURPOSE: We conducted a randomized, single-blind clinical trial comparing the surgical outcomes of robotic-assisted fluoroscopic-guided (RAF group) and ultrasound-guided (US group) renal access in mini-percutaneous nephrolithotomy (PCNL). MATERIALS AND METHODS: We recruited patients who underwent mini-PCNL with ureteroscopic assistance for large renal stones between January 2020 and May 2021. Block randomization was performed using online software. Automated needle target with x-ray was used for fluoroscopic-guided renal access in the RAF group. PCNL was performed by residents using a pneumatic lithotripsy system with 16.5Fr/17.5Fr tracts. The primary outcome was single puncture success, and the secondary outcomes were stone-free rate, complication rate, parameters measured during renal access and fluoroscopy time. RESULTS: In total, 71 patients (35 in US group, 36 in RAF group) were enrolled. No difference was seen in the single puncture success rate between the US and RAF groups (34.3% and 50.0%, p=0.2). In 14.3% cases in the US group vs no cases in the RAF group, the resident was unable to obtain access due to difficult targeting (p=0.025). The mean number of needle punctures was significantly fewer, and the median duration of needle puncture was shorter in the RAF group (1.83 vs 2.51 times, p=0.025; 5.5 vs 8.0 minutes, p=0.049, respectively). The stone-free rate at 3 months after surgery was 83.3% and 70.6% in the RAF and US groups, respectively (p=0.26). Multivariate analysis revealed that RAF guidance reduced the mean number of needle punctures by 0.73 times (p=0.021). CONCLUSIONS: RAF renal access in mini-PCNL may have further potential applications in this field.